Men's Health ScreeningiScreenMenNCT06388473
Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting
A study testing Tailored implementation intervention in people with Men's Health Screening and Implementation, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Men's Health Screening, Implementation, Web-based Application
- What is being tested?
- Tailored implementation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 Jan 2021to 6 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare providers that were involved in the clinic health screening program.
- Patients who were aged 18 years and above were eligible to participate.
Who cannot join
- Temporary healthcare providers (working in the clinic less than six months during the study period) and those who were away on leave.
- Patients who did not understand Bahasa Malaysia, English or Mandarin, cognitively impaired, had an active psychiatric illness or were too ill.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months.
- Being tested
- Tailored implementation intervention
- Keywords
- mass screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored implementation interventionBehavioural
Also called ScreenMen
The tailored implementation intervention comprised of six implementation strategies: 1) Involve executive boards, 2) Mandate change, 3) Provide education and training, 4) Identify and prepare champions, 5) The use of information and communication technology and 6) Audit and provide feedback.
| Study group | Role | What they receive |
|---|---|---|
| Tailored implementation intervention | Experimental | The tailored implementation intervention comprised of six implementation strategies: 1) Involve executive boards, 2) Mandate change, 3) Provide education and training, 4) Identify and prepare champions, 5) The use of information and communication technology and 6) Audit and provide feedback. Receives: Behavioral: Tailored implementation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Number of healthcare providers who attended the workshop / Number of healthcare providers who were invited to the workshop.
Measured: Beginning of intervention
Reach
The number of patients who accessed ScreenMen.
Measured: Through study completion, 5 months.
Adoption of ScreenMen using qualitative methods
Factors affecting the participation of healthcare providers in adopting ScreenMen in daily practice using qualitative interviews.
Measured: 5 months into study
Implementation of ScreenMen using qualitative methods
Factors affecting the implementation of ScreenMen daily practice using qualitative interviews.
Measured: 5 months into study
Maintenance of ScreenMen using qualitative methods
Intention to implement ScreenMen and factors influencing the decision using qualitative methods.
Measured: 5 months into study
Secondary outcomes (1)
Impact of COVID-19 on the clinic using qualitative methods
The clinic situation during the COVID-19 pandemic and how it affected daily practice using qualitative methods.
Measured: 5 months into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start14 Jan 2021
- Primary completion6 Jun 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Men's Health ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chirk Jenn Ng, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388473
- Sponsor's protocol ID
- NMRR-20-2188-56086 IIR
- Acronym
- iScreenMen
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ooi CY, Ng CJ, Sales A, Teo CH. Pilot implementation study of a web-based men's health screening app in primary care during COVID-19: a mixed-methods approach. BMC Health Serv Res. 2024 Oct 11;24(1):1219. doi: 10.1186/s12913-024-11702-9.
PubMed 39394132
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting
- ClinicalTrials.gov ID
- NCT06388473
- Acronym / sponsor ID
- iScreenMen / NMRR-20-2188-56086 IIR
- Keywords
- mass screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored implementation intervention | Experimental | Behavioral: Tailored implementation interventionThe tailored implementation intervention comprised of six implementation strategies: 1) Involve executive boards, 2) Mandate change, 3) Provide education and training, 4) Identify and prepare champions, 5) The use of information and communication technology and 6) Audit and provide feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare providers that were involved in the clinic health screening program.
- Patients who were aged 18 years and above were eligible to participate.
Key exclusion criteria (2 listed)
- Temporary healthcare providers (working in the clinic less than six months during the study period) and those who were away on leave.
- Patients who did not understand Bahasa Malaysia, English or Mandarin, cognitively impaired, had an active psychiatric illness or were too ill.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored implementation interventionAlso: ScreenMenThe tailored implementation intervention comprised of six implementation strategies: 1) Involve executive boards, 2) Mandate change, 3) Provide education and training, 4) Identify and prepare champions, 5) The use of information and communication technology and 6) Audit and provide feedback. | Behavioural | Tailored implementation intervention |
Primary outcome
Reach
Time frame: Beginning of intervention
Number of healthcare providers who attended the workshop / Number of healthcare providers who were invited to the workshop.
Reach
Time frame: Through study completion, 5 months.
The number of patients who accessed ScreenMen.
Adoption of ScreenMen using qualitative methods
Time frame: 5 months into study
Factors affecting the participation of healthcare providers in adopting ScreenMen in daily practice using qualitative interviews.
Implementation of ScreenMen using qualitative methods
Time frame: 5 months into study
Factors affecting the implementation of ScreenMen daily practice using qualitative interviews.
Maintenance of ScreenMen using qualitative methods
Time frame: 5 months into study
Intention to implement ScreenMen and factors influencing the decision using qualitative methods.
1 secondary outcome
Impact of COVID-19 on the clinic using qualitative methods
Time frame: 5 months into study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Derived from this study: PubMed 39394132Ooi CY, Ng CJ, Sales A, Teo CH. Pilot implementation study of a web-based men's health screening app in primary care during COVID-19: a mixed-methods approach. BMC Health Serv Res. 2024 Oct 11;24(1):1219. doi: 10.1186/s12913-024-11702-9.
- Individual participant dataSharing planned: No
Related trials for Men's Health Screening
RecruitingObservational study
Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Testosterone Deficiency, Male Hypogonadism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chirk Jenn Ng, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored implementation intervention in people with Men's Health Screening and Implementation, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Beginning of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.